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Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00146614
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : March 8, 2012
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Edwin P. Alyea, MD, Dana-Farber Cancer Institute

Study Description
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Brief Summary:
The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD) after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication; sirolimus, tacrolimus and methotrexate.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Hematologic Malignancies Drug: Sirolimus Drug: Tacrolimus Drug: Methotrexate Procedure: Stem Cell Transplantation Phase 2

Detailed Description:
  • Patients will be admitted to the hospital and receive chemotherapy and stem cell transplant(SCT). The total duration of hospitalization for the procedure is approximately 8 days. Once admitted the patient will receive fludarabine daily for 4 days, busulfex once daily for 4 days. Two days after chemotherapy has ended, the patient will receive the infusion of donor cells.
  • Just prior to the transplant and following the transplant, patients will receive sirolimus (orally), tacrolimus (orally) and low doses of methotrexate (chemotherapy). Methotrexate will be given on days 1,3 and 6 after transplant.
  • Sirolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
  • Tacrolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
  • Patients will also receive medication to help prevent possible infection.
  • After stem cell infusion, patients will be examined and have blood tests weekly for 1 month. At the 1 month visit, a bone marrow biopsy will performed looking for evidence of donor cells in the bone marrow. After the one month evaluation the patient will be examined every 2 weeks and a repeat bone marrow performed 3-4 months after transplant.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation
Study Start Date : July 2002
Actual Primary Completion Date : April 2003
Actual Study Completion Date : April 2003

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation.
  • Donors (both related and unrelated) who are identical at 6 HLA loci.
  • Age greater than 18
  • ECOG Performance Status 0-2
  • Life expectancy of greater than 100 days.

Exclusion Criteria:

  • Pregnancy
  • Evidence of HIV infection
  • Heart failure uncontrolled by medications
  • Total Bilirubin > 2.0mg/dl due to hepatocellular dysfunction
  • AST > 90
  • Serum creatinine > 2.0
  • Cholesterol > 300 mg/dl
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146614


Locations
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United States, Massachusetts
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Investigators
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Principal Investigator: Edwin P. Alyea, MD Dana-Farber Cancer Institute
More Information
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Responsible Party: Edwin P. Alyea, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00146614    
Other Study ID Numbers: 02-057
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012
Keywords provided by Edwin P. Alyea, MD, Dana-Farber Cancer Institute:
Graft versus Host Disease
GVHD
Stem Cell Transplantation
Tacrolimus
 Sirolimus
Methotrexate
allogeneic stem cell transplantation
Additional relevant MeSH terms:
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Hematologic Neoplasms
Graft vs Host Disease
Neoplasms
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Sirolimus
Methotrexate
Tacrolimus
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Calcineurin Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents